Accessory to syringes

ABSTRACT

An accessory for temporary, contamination-free holding of closing stoppers used for syringes and other medical care devices, where the accessory comprises a stopper designed for coupling to a recess in another existing stopper or a carrier that can be combined with a stopper. The carrier has a lower part, which may be designed as a substitute for an existing stopper; a mid-piece, which is inserted in or over an existing stopper; a rider for placing over a curved surface such as a syringe body; or a carrier-foot for fastening onto suitable surfaces.

TECHNICAL FIELD

The invention relates to a method and accessory for thecontamination-free keeping of stoppers used in medical care. The fittingcomprises a stopper or carrier which is temporarily placed upon syringesor other equipment to prevent entry of contamination while awaiting useof the syringe.

BACK GROUND ART

The medical care needs often to establish connection to the patient'shypodermic tissues via syringes, tubes or containers of different kinds.The connection must be established with total sterility. Leakage andunwanted contact must be avoided as far as possible. Such unintendedcontact, especially with blood and blood vessels, may involve a veryserious risk of infection.

Examples of treatments requiring blood vessel connection are bloodtransfusion inclusive blood giving, blood sampling assisted by testcontainers under negative pressure, and intravenous supply of medicine,nourishment or just liquid for blood volume expansion, commonly called adrip.

A frequently used syringe for insertion in blood vessels of differentkinds has a tube body with a channel that continues in a thin and softplastic tube. The rear port of the tube body is shaped as a conicalcavity and, at the beginning, closed by a hollow needle and a needlebody, the rear part of which has a transparent signal chamber, whichgets filled with blood, when satisfactory blood vessel contact has beenestablished. The rear wall of the signal chamber is liquid-tight andprevents blood shedding through the rear opening of the needle body.This opening is used for temporary placement of a stopper intended fortightening the rear port of the tube body, when the needle has beenwithdrawn.

To establish a blood vessel connection one choses a suitable,superficial blood vessel (vein or artery depending upon type oftreatment) and tries to direct the tip of the puncture needle topenetrate the skin just over the chosen blood vessel, so that the tiphits the vessel centrally and, after penetration of the vessel wall,with the plastic tube can be directed into the blood path. When theabove mentioned transparent room behind the needle starts filling withblood, the syringe is advanced a little (about 2 mm) to ensure completepenetration of the vessel wall. Then the needle body with the belongingpuncture needle is kept still, while the tube is advanced so that theneedle tip no longer is in front of the end of the plastic tube. This isdone to prevent the needle tip from hurting the vessel wall. Finally thesyringe is advanced to its desired position and kept there.

After that the puncture-needle is withdrawn. To prevent blood sheddingthrough the rear opening of the tube body, which has been tightened bythe needle body, the withdrawal is begun by the operator by compressing,with one of his or her hands, the skin area over the tip of the plastictube, until he or she has withdrawn the puncture needle and applied theintended stopper in the rear end of the tube body.

This is a critical moment concerning leakage. As seen above the operatorhas just one hand free (usually the right hand). The other hand is usedfor tissue compressing. With the free hand the operator has to loosenthe stopper from the needle body and, without contaminating the stopper,move it to the rear end of the tube body. The needle body may have to belet free for grip changing before the stopper can be removed. Theoperation is not simple even under good circumstances in a ward unit. Ifit instead has to be done in a forth-rushing ambulance by personnel withlittle syringe handling education, the difficulties become even worse.

The risk is large that the needle body rolls away. The risk is alsolarge that the stopper is dropped and lost and/or becomes contaminatedbefore getting placed in the rear port of the tube body. In both casesthe operator needs help, if not the whole operation should have to berepeated with a new sterile syringe.

Trials have been made earlier (The Swedish laid open publication no 355946) to place the tube body stopper at one of the tube body's wings.This placing has shown to be less convenient, as the stopper gets in theway and hampers the vessel puncture.

The problem of sterile between-handling is not limited to blood vesselentries. It appears in a row of clinical situations for exampleirrigation (rinsing) at surgical operations and respirator treatments tomention a few examples. The circumstances at these situations are inhigh degree analogous with those at intravenous entry and the moredetailed description is therefore limited to the circumstances at venouspunctures.

SUMMARY OF THE INVENTION

The purpose of this invention is to solve the problem of between keepingand availability of stoppers under circumstances preventingcontamination. According to this new method the stopper is coupled tothe device so it does not hamper actual operation, is nearby and can beeasily loosened and placed in the intended opening, without the risksmentioned above of getting lost or contaminated.

Further the invention concerns fittings to syringes of the typedescribed above, i.e. consisting of a tube body and a needle body andother medical care devices with similar stoppers. The fitting mayconsist of a stopper designed for coupling to a recess in anotherexisting stopper or a carrier, which may be combined with a stopper. Thecarrier has a lower part, which may be designed as a substitute for anexisting stopper, a mid-piece, which is inserted in or over an existingstopper, a rider for placing over curved surfaces or a plane foot forfastening at suitable surfaces.

The requirement, that the coupling must be done without letting thestopper hamper the handling of the syringe, rules out earlier mentionedplacing at one wing of the tube body. If the syringe is provided with anupper port and a stopper belonging to this port placing at its uppersurface is preferred. Concerning syringes that do not have suitablesurfaces for the temporary placing of the end stopper the stopper of theinvention is combined with a carrier for instance in the shape of arider, which can be placed at a suitable location at the tube body.Altered design of the tube body may also provide new surfaces suitablefor temporary placing of the end stopper. The same is valid for otherequipment, too.

For devices with a design that makes riders not suitable, the rider canbe substituted with a carrier-foot according to the Swedish patentapplication no 9500800-9.

The coupling between the tube body and the stopper must be done so thatno increased risks of contaminating surfaces with potential bloodcontact are produced. One possibility is that the coupling is done whenthe sterile packed syringe is taken from the package and before thesurface, where the coupling takes place, has been touched. Anotherpossibility is to protect the surface with a protecting tape until thecoupling moment. The first possibility is preferred if stopper andsyringe is in separate packages. The second may be of interest if thefitting is by-packed the syringe.

Coupling to an existing upper stopper can be done via a slenderoutgrowth 2.212' at the cone-formed closing part of the end stopper2.212 designed to fit the recess in the upper tube body stopper 2.31 oranother suitably seized recess at the tube body. The outgrowth may withadvantage be designed as a rod passing through a bore in the stopper andbeing pressed in when the coupling is done.

Conical stoppers of this kind are often used in the medical care and arethe subject of a standard that is usually called Luer-cone (ISO-standard594/1-2).

An alternative to using a stopper as above is that the fitting consistsof stopper 2.31' that substitutes the upper tube body stopper 2.31. Theupper part of the substitute stopper is designed so that its formfunctionally matches the rear opening of the needle body and thus issuitable to serve as "parking place" for the existing end stopper. Toprevent misunderstanding it should be remarked that the rear opening ofthe needle body is a blind port, the sole function of which is to keepand protect the end stopper from contamination, until it is used forclosing the rear port of the tube body. All designs that fulfill thispurpose thus match the rear opening of the needle body from thefunctional point of view.

It may for instances be an edge that surrounds a recess fitting theprotruding conical closing part 2.212 of the end stopper 2.21 or acone-formed, inner recess and an outer tube-formed part that togethermatch the rear opening of the needle body, or an essentially conicaltube-piece that by spring force engages the inner wall of the endstopper's mantle. Different variants and combinations of these designsmay be used for different syringe types. Besides these already mentionedarrangements one may also use a design with a slitted or bead providedtube-piece, which by spring-force grasps around the outer mantle of theend-stopper.

As an alternative to modification of the upper tube body stopper amid-piece may be used, which has a lover part with an outgrowth of thetype mentioned for the end-stopper or a lover tube-formed part adaptedfor a suitable firm and flexible fit around the upper tube bodystopper's upper part and an upper part that functionally matches therear opening of the needle body, i.e. is designed analogously with theupper part of the alternative upper stopper described.

If the fitting is sold separately, the design with a tube-part graspingaround the outer mantle of the end-stopper may be of special interest,as it, with relative ease, can be made to fit most of the syringe typesthat are present on the market. Besides this design is less demanding ofcomplete sterility at the handling, as no surfaces that may meet bloodhave to be touched.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a syringe with an upper port.

FIG. 2a is side view of a syringe without upper port and provided with arider for temporary placing of a tube body stopper of the invention.

FIG. 2b is a plan view of a syringe without an upper port and providedwith a rider for temporary placing of a tube body stopper of theinvention.

FIG. 3a depicts a cross-sectional view of the upper part of a typicalprior art stopper.

FIG. 3b depicts a partially-sectioned side view of the stopper of FIG.3a.

FIG. 4 shows a design of to FIG. 4a depicts a cross-sectional view ofthe upper part of a stopper according to the invention.

FIG. 4b depicts a partially-sectioned side view of the stopper of FIG.4a.

FIG. 5 shows a section of a rider intended for use on syringes accordingto FIG. 2a along the line 5--5.

FIG. 6 shows a syringe like FIG. 1 provided with a stopper according tothe invention placed upon the upper tube body stopper.

FIG. 7 shows a syringe like FIG. 1 provided with a variant of an uppertube body stopper according to the invention.

FIG. 8a depicts a partially sectioned side view of a mid-piece intendedfor use on syringes with an upper stopper and an upwards open recess inthis stopper.

FIG. 8b depicts a cross-sectional view of the mid-piece of FIG. 8a.

FIG. 9a depicts a partially sectioned side view of a mid-piece intendedfor use at syringes with an upper stopper without upwards open recess.

FIG. 9b depicts a cross-sectional view of the mid-piece of FIG. 9a.

FIG. 10a depicts a partially sectioned side view of a carrier-foot,which can be used for application at equipment with plane surfaces.

FIG. 10b depicts a plan view of the carrier foot of FIG. 10a.

FIG. 11a depicts a cross-sectional view of the upper part of a typicalprior art stopper.

FIG. 11b depicts a partially sectioned side view of the prior artstopper of FIG. 11a.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows one of the often used syringes for entry in blood vesselsof different kinds. The syringe consists of a tube body 2 with a channelthat continues in a thin and soft plastic tube 2.1. The rear opening ofthe tube body 2.2 is shaped as a conical cavity and, from the beginning,closed by the tube-formed needle 1.1 and the needle body 1, which hasbeen marked by slanting lines. The rear part of the needle body has atransparent signal chamber 1.2, which gets filled with blood, whensatisfactory blood path contact has been established. The rear wall 1.21of the signal chamber 1.2 is liquid-tight and prevents blood sheddingout of the rear opening 1.3 of the needle body. This opening is used fortemporary placing of the stopper 2.31 intended for closing the rearopening 2.2 of the tube body, when the needle has been withdrawn. Besidethe opening 2.2 the tube body 2 has another opening 2.3 used forconnection to injectors etc. This opening in closed by the stopper 2.31,which centrally has an upwards open axial recess 2.311. Such recessesare, as a rule, present at stoppers of similar kinds and serve toprevent dimension changes at manufacturing by pressure moulding.

FIGS. 2a and 2b shows another often used syringe without upper port.Apart from that and the fact that it has been provided with a rider 3,placed over the tube body abreast with its wings and designed with arecess 3.1 for the stopper 2.2, the design of this syringe correspondswith the one according to FIG. 1.

FIGS. 3a, 3b, 11a and 11b show the stoppers, usually belonging to thesyringes of FIG. 1 and 2, in larger scale. FIGS. 4a and 4b shows onedesign of a stopper according to the invention. In both cases thestopper has a protruding, central, slightly cone-formed part 2.212, thepurpose of which is closing of the slightly conical opening 2.2 of thetube body 2 and a protecting, cylinder-formed mantle 2.213, whichdepending upon the supplier of the syringe may have different length andsometimes covers the closing part entirely. According to the design ofFIGS. 4a and 4b the stopper is provided with a tapering outgrowth(length about twice the diameter) 2.212' of the conical part 2.212. Thediamete r of the outgrowth is chosen so it with moderately firm couplingcan be inserted into the recess 2.311 of the stopper 2.31. As mentionedabove the outgrowth may with advantage be designed as a rod passingtrough a bore in the stopper 2.31 and being pressed in, when thecoupling is done.

FIG. 5 shows a rider, which can be used to get a suitable place fortemporary keeping of the end-stopper of syringes lacking upper port. Thelower part has a recess 3.2 in the shape of a cut cylinder with part ofthe mantle removed. The recess is made so the rider can be placed upon asyringe like FIG. 2 abreast with the wings. The upper part of the ridercan have a recess 3.1 adapted for receiving a modified stopper or amid-piece as above, which here accompanies the rider. Another betteralternative is, of course, an upper part with principally the samedesign as the upper part of the mid-piece.

FIGS. 8a and 8b, 9a and 9b show two different designs of mid-pieces thathave been found especially suitable. In the FIGS. 4.1 stands for theupper part and 4.2 respectively. 4.2' for the lower part. In FIGS. 8aand 8b the lower part 4.2 consists solely of an outgrowth adapted to fitinto the recess of the upper stopper. In FIGS. 9a and 9b the lower parthas been designed to fit over the upper stopper 2.31 even if it islacking upwards open recess. Upper stoppers have as a rule a "strap"2.311 that anchors it to the tube body. The mantle of the lower part ofthe mid-piece is therefore provided with a longitudinal recess 4.211.

FIGS. 10a and 10b shows a carrier-foot 5 that with advantage may be usedat equipment with plane surfaces near the place, where the stopper isused. The footplate 5.2 should be prepared so it, after removing aprotecting film, sticks to the surface permanently or temporarydepending on the need. The upper part 5.1 may with advantage be designedanalogously with the mid-pieces of the FIGS. 8 and 9.

Riders according to FIG. 5, carrier-feet as in FIGS. 10a and 10b andmid-pieces of the types shown in FIGS. 8a, 8b, 9a and 9b can be designeds o they can be used without sterilizing. A condition for this is thatthey in a reliable way can be handled without making contact betweensurfaces that may meet blood and tissues and not sterilised surfaces. Tofacilitate insertion of the stopper 2.21 in the upper part, withoutmaking unintended contacts, the upper part is provided with a guide rail4.11 that makes the insertion of the stopper easier.

To amend the fit between the mid-piece and the upper stopper of the tubebody the lower part of the mantle 4.22 may be provided with yieldingedgings 4.221. Similar edgings may be used for the upper part too.Another alternative to effect required, firm keeping, without causingproblems at loosening, is longitudinal notches or beads at the innerside of the tubes. The same is true, if applicable, forcarrier-stoppers, riders and carrier-feet.

The new accessory may be marketed as a separate unit or by-packed thesyringe or device. As already mentioned the rear opening of the needlebody is a blind port, the sole purpose of which is keeping andprotecting the end-stopper. A modified stopper or a mid-piece with aninserted stopper may be placed there, if the rear end of the needle bodyis modified. Another possibility is that a mid-piece is placed in theend-stopper's recess and moved to the upper stopper at the start of theoperation. The proposed possibilities are examples and should not beconsidered as limiting the invention.

It is claimed:
 1. A combination comprising a separate closing stopperand a blood vessel access device which includes a tubular body having adistal port that receives the closing stopper therein and a proximalportion that includes a needle, the improvement which comprises afitting for temporary coupling with and support of the closing stopperwhen the closing stopper is removed from the distal port of the tubularbody, which fitting comprises a separate carrier foot (5) having a baseportion and a body portion extending from the base portion, wherein thebody portion includes support means for temporary association of thestopper therewith when the stopper is removed from the distal port ofthe blood vessel access device.
 2. The combination of claim 1 whereinthe base portion of the carrier foot comprises at least two planarmembers for application on a flat surface.
 3. The combination of claim2, wherein the support means of the body portion of the separate carrierfoot includes a recess for receiving a portion of the closing stopper.4. The combination of claim 2, wherein the closing stopper includes arecess for receiving a portion of the carrier foot support means.
 5. Ina blood vessel access device that includes a tubular body for deliveringa fluid and a separate closing stopper, the tubular body having ahousing, a distal end and a proximal end, the distal end including adistal port for receiving the closing stopper and the proximal endincluding a needle the improvement which comprises a fitting associatedwith the housing and comprising support means for temporarily holdingthe closing stopper when the closing stopper is removed from the distalport of the blood vessel access device.
 6. The device of claim 5 whereinthe which fitting is an embossment which is integral with the housing ofthe tubular body.
 7. The device of claim 5 which further comprises acarrier-stopper adapted to close the distal port, said carrier-stopperhaving an upper surface with a recess, wherein the support means of thefitting comprises an extension which is adapted to be received by therecess of the carrier-stopper.
 8. The device of claim 5 wherein thesupport means of the fitting comprises a specially-designedcarrier-stopper adapted for closing the distal port, wherein thespecially-designed carrier-stopper has an upper part configured tosupport the closing stopper.
 9. The device of claim 8 wherein the upperpart of the specially-designed carrier stopper has a recess forreceiving a portion of the closing stopper.
 10. The device of claim 8,wherein the closing stopper has a recess for receiving the upper part ofthe specially-designed carrier stopper.
 11. The device of claim 5 whichfurther comprises a carrier-stopper adapted to close the distal port,wherein the support means of the fitting comprises a mid-piece having anupper part configured to engage the closing stopper; and a lower partconfigured for attachment to the carrier stopper.
 12. The device ofclaim 11, wherein the upper part of the mid-piece includes a recess forreceiving a portion of the closing stopper.
 13. The device of claim 11,wherein the closing stopper includes a recess for receiving a portion ofthe upper part of the mid-piece.
 14. The device of claim 11, wherein thelower part of the mid-piece has a recess that receives a portion of thecarrier stopper.
 15. The device of claim 11, wherein the carrier stopperhas a recess that receives a portion of the lower part of the mid-piece.16. The device of claim 5 wherein the fitting comprises a riderassociated with the tubular body and having an lower part and a upperpart, wherein the lower part is provided with a recess for engaging thehousing of the tube body, and wherein the upper part is configured tosupport the closing stopper.
 17. The device of claim 16 wherein theupper part of the rider has a recess for receiving a portion of theclosing stopper.
 18. The device of claim 16 wherein the closing stopperhas a recess for receiving a portion of the upper part of the rider. 19.The device of claim 5 which further comprises a carrier-stopper adaptedto close the distal port, wherein the carrier-stopper includes a guiderail to facilitate the insertion of the closing stopper therein.